Dental Caries
Conditions
Brief summary
The goal of this clinical trial is to learn if polymer-induced liquid precursor (PILP) can be used safely to treat dentin caries (cavities) in adults. The main question it aims to answer is: Is PILP (conditioner or liner) safe in adult teeth with dental caries? Researchers will compare PILP to a placebo (a look-alike substance that contains no drug) to see if PILP safely treats cavities in teeth. Participants will: 1) Have PILP or placebo applied to their tooth prior to the placement of a filling in the tooth, 2) Complete two telephone calls within three months of filling placement and 3) Visit the clinic at three months and six months after the placement of the filling.
Detailed description
The proposed study is a first-in-human safety evaluation of Polymer-Induced Liquid Precursor (PILP)-releasing dental materials for the treatment of deep carious lesions in adult posterior teeth. The study will enroll adult patients diagnosed with carious lesions involving the dentin. Participants will be randomly assigned to one of three intervention groups. The primary objective is to assess the safety of PILP application, with a hypothesis that PILP can be safely used without causing adverse events to the tooth or patient. Participants will undergo a series of visits starting with a comprehensive screening and consent process, followed by the assigned dental procedure involving caries removal and restoration. Follow-up evaluations will occur at 48 hours, 1 month, 3 months, and 6 months post-procedure to monitor for any symptoms or adverse outcomes.
Interventions
DEVICEPILP Cement
PILP cement liner.
DEVICEPILP Conditioner
PILP solution.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Stated willingness to comply with all study procedures and availability for the duration of the study 2. Male or female, aged 18 to sixty-four 3. In good general health as evidenced by medical history (ASA 1 or 2) 4. With at least one posterior tooth with caries to dentin 1. The tooth must have a pulpal diagnosis of pulpal health (no irreversible pulpitis or periapical radiolucency) 2. The tooth should have no existing restorations 3. The caries should be a Class I or class V single surface lesion 4. The tooth should be planned for restoration with intra-coronal restoration (composite or RMGI restoration) 5. The tooth should be deemed as needing a restoration based on ICDAS (International Caries Detection and Assessment System)
Exclusion criteria
Known allergic reactions to components of the study device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulpal response | Tooth vitality testing will occur approximatley 3 months and 6 months after placement of the restoration. | Tooth vitality (pulpal response) after intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dental pain/sensitivity | Tooth pain will be assessed at 48 hours, 1 month, 3 month and 6 months after placement of the restoration. | The dental pain/sensitivity assessment will include Visual Analog Scale (VAS) for dental pain. |
| Gingival Inflammation | Gingival inflammation will be assed by intra-oral clinical exam at 3 and 6 months post restoration placement. | Intra-Oral Assessment and Photographs will assess gingival inflammation (Löe-Silness gingival index). |
| Periapical status | A dental radiograph of the tooth will be take at 3 and 6 months post restoration placement. | Dental radiographs will assess periapical status (periapical index) |
Countries
United States
Contacts
CONTACTJean Star, DDS, MPH
CONTACTJessica Snider, MBA
PRINCIPAL_INVESTIGATORStefan Habelitz, PhD
Stefan Habelitz, PhD
Outcome results
None listed